BEUDAMED
    FDA Recall Terminated

    The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.

    Recall: Z-1084-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1084-2015
    Event Number
    70088
    Firm
    Integra LifeSciences Corporation
    FEI Number
    3004608878
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 19, 2014
    Posted
    February 10, 2015
    Terminated
    February 22, 2017
    Address
    4900 Charlemar Dr, Bldg A, Cincinnati, OH, 45227-1402

    Description

    The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.

    Reason

    Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

    Action

    Integra sent an Urgent - Voluntary Medical Device Recall letter dated December 19, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 1. Review your MAYFIELD equipment and determine if you have any MAYFIELD Ultra 360 Base Units 2. Once identified we recommend that you discontinue use and remove them from service until they are repaired by an authorized Integra Repair Center 3. Complete the attached Recall Acknowledgement and Repair Form 4. Upon receipt of the Recall Acknowledgement and Repair Form, Customer Service will contact you and provide an RMA number and instructions for returning the productor questions call 609-936-6822. For questions contact Customer Service: USA 800-654-2873 Outside USA 609-936-5400

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, COLUMBIA, CYPRESS, DENMARK, DOMINICAN REPUBLIC, FRANCE, GERMANY, GREAT BRITAN, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN , JORDAN, KOREA, LIBYA, MACEDONIA, MAYLASIA, MEXICO, NETHERLANDS, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, TAIWAN, THAILAND, and TURKEY.

    Quantity

    1053 Units